Law Commons^™

Rebutting Obviousness In The Pharmaceutical Industry: Secondary Considerations Of Analogs, Jolie D. Lechner

Chicago-Kent Journal of Intellectual Property

Pharmaceutical companies depend on patent protection to recuperate the high costs of research and development. In regards to the patentability of structurally related compounds, the courts must decide whether a compound is obvious in view of its structurally similar prior art. In general, a compound is non-obvious over the structurally related prior art if the compound exhibits unexpected results. However, placing primary emphasis on a compound's unexpected properties is out of step with the realities of drug development. For example, during drug development, chemists will modify a compound's structure until they produce a compound that exhibits optimal pharmakinetic properties. This …

Designer Collaborations As A Solution To The Fast-Fashion Copyright Dilemma, Arielle K. Cohen

Chicago-Kent Journal of Intellectual Property

This article explores the issue of large retailers capitalizing on designers’ designs by using the method of “close copying” and the dilemma that designers face due to their lack of recourse since their designs are not afforded copyright protection. The Council of Fashion Designers of America has been lobbying Congress for protection and their efforts have created the Innovative Design Protection and Piracy Prevention Act. This legislation is currently pending but it is a revised version of the earlier Design Piracy Prohibition Act and it removes many of the controversial provisions that were in the earlier version. Therefore, there is …

Funk Brothers - An Exercise Obviousness, Shine Tu

Law Faculty Scholarship

No abstract provided.

A Philosophical Analysis Of Intellectual Property: In Defense Of Instrumentalism, Michael A. Kanning

USF Tampa Graduate Theses and Dissertations

This thesis argues in favor of an instrumental approach to Intellectual Property (IP). I begin by reviewing justifications for IP that have been offered in recent literature, including Lockean labor theory, Hegelian personality theory, Kantian property theory and utilitarianism. Upon a close and careful analysis, I argue that none of these justifications suffice to ground contemporary IP practice. I review some recent works that offer `pluralist' justifications for IP, which draw from multiple theories in order to account for the diverse field of IP-related laws and practices in existence. I argue that these pluralist theories are also insufficient, because there …

Patent Chokepoints In The Influenza-Related Medicines Industry: Can Patent Pools Provide Balanced Access?, Dana Beldiman

Dana Beldiman

This paper illustrates the fact that when biological materials are used for development of pharmaceuticals, the patent system may function sub-optimally and may give rise to patent “thickets” and “anti-commons” which prevent commercialization of adequate amounts of product. These circumstances include inventions based on the same biological resource, patenting of largely similar functionalities, gene patents and patents that are narrow and fragmented. As a result, in order to obtain freedom to operate, drug developers must license-in multiple patents, often from competitors. This situation gives rise to uncertainty and is prone to hold-outs. The number of players actually developing drugs is …

Illuminating Innovation, Lea B. Shaver

Lea Shaver

The central justification offered for patent protection is the need to incentivize technological innovation. Yet to date there is little empirical evidence that this aim is achieved. This Article argues that historical case studies, exploring the impact of patent law on particular fields of technological innovation, can be especially helpful in providing an empirical foundation for patent scholarship. The Article then proceeds to offer one such case study, focused on one of the most important technological revolutions of the past two centuries: electrification. Although Thomas Edison and “the incandescent lamp” have been extensively studied, so far no one has asked …

Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd

Brendan O. Baggot

How can universities make more money with their spinout company (SpinCo)‐suitable technologies? By “growing” their own CEOs to improve both the quality and quantity of startup company leaders available, that’s how. Surprisingly, however, at most universities little or no effort is made to interweave this critical need into tech transfer efforts.

Will Gene Patents Derail The Next-Generation Of Genetic Technologies?: A Reassessment Of The Evidence Suggests Not, Christopher M. Holman

UMKC Law Review

Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing." His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that …

Patent Validity Across The Executive Branch: Ex Ante Foundations For Policy Development, Arti K. Rai

Duke Law Journal

Among patent scholars who address institutional questions, many favor the courts over the PTO as the policymaker of choice. Even though courts have familiar limitations with respect to policymaking, scholars often argue that the PTO is more likely to be captured. This Essay argues that the capture story has significant limits, particularly in key cases where PTO decision making has been influenced by other executive-branch decision makers. Meanwhile, exclusive reliance on ex post judicial development can yield a one-way ratchet towards the expansion of patent protection. When courts expand patent rights, they generally do not have to worry about retroactive …

The Myth Of Generic Pharmaceutical Competition Under The Hatch-Waxman Act, Emily Michiko Morris

Fordham Intellectual Property, Media and Entertainment Law Journal

Without a doubt, health care costs are on the rise, and how to reduce those costs is of great concern to many. The Hatch-Waxman Act attempts to reduce pharmaceutical costs by encouraging market entry by lower-priced generic pharmaceuticals and without a doubt has been successful in doing so over the last three decades. The question is, at what price? Although designed to balance greater generic market entry with stronger incentives for brand-name pharmaceutical innovators to continue developing new drugs, the Act appears to have fall short of making those incentives nearly strong enough and, indeed, likely weakens them. Perhaps more …

Transcending The Tacit Dimension: Patents, Relationships, And The Industrial Organization Of Technology Transfer, Peter Lee

Peter Lee

As a key driver of innovation and economic growth, university-industry technology transfer has attracted significant attention. Formal technology transfer, which encompasses patenting and licensing university inventions, is often characterized as proceeding according to market principles. According to this dominant conception, patents help commodify academic inventions, which universities then advertise and transfer to private firms in licensing markets.

This Article challenges and refines this market-oriented view of technology transfer. Drawing from empirical studies, it shows that effective technology transfer often involves long-term personal relationships rather than discrete market exchanges. In particular, it explores the significant role of tacit, uncodified knowledge in …

Settlement Of India/Eu Wto Dispute Re Seizures Of In-Transit Medicines: Why The Proposed Eu Border Regulation Isn't Good Enough, Brook Baker

Brook K. Baker

European Customs officials have used fictive patent rights to justify the seizure of lawful generic medicines produced in India and destined for non- European markets. Following a public outcry and initiation of two WTO complaints, the EU has proposed amendments to Border Regulations Measure 1383/2003. The Proposed Border Regulation in its current form will not adequately resolve the risk of interception in Europe of medicines lawfully manufactured and exported from India and destined for lawful import and consumption in a non-EU country. This analysis concludes that multiple weaknesses remain in the Border Regulations, including: (1) continued coverage of alleged patent …

Limits On Utility In The Face Of 21st Century Invention: The Problem With Limiting Patent Claims On Est Sequences, Kyle Strache

The Journal of Business, Entrepreneurship & the Law

No abstract provided.

Patent Law—Patentability Post-Bilski: No Need To Throw The Baby Out With The Bath Water When Determining Subject Matter Eligibility Under 35 U.S.C. § 101, Jennifer L. Davis

University of Arkansas at Little Rock Law Review

Pursuant to Title 35, §101 of the United States Code, anyone who "invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof" is eligible for a patent. Traditionally, the United States Patent and Trademark Office and the federal courts have enumerated a variety of tests for determining patent eligibility, but common language in the case law had lead to, in Bilski v. Kappos, 130 S. Ct. 3218 (2010), the development of what is known as the machine-or-transformation test. In an opinion delivered on the final day of the 2009-2010 …

Professional And Academic Employee Inventions: Looking Beyond The Uk Paradigm, Justine Pila

Justine Pila

The vast majority of inventions are devised by employees, raising the question who is entitled to patent them? Under the UK Patents Act 1977, the right to patent an invention lies primarily with its inventor(s). However, an exception exists for employee inventions to which section 39(1) applies. The recent decision of the Full Court of the Federal Court of Australia in UWA v Gray raises the question of the applicability of this provision in the university context, in respect of regular academic employees. In that case, the Court relied on UK authorities to support its conclusion that the University of …

‘Sewing The Fly Buttons On The Statute:’ Employee Inventions And The Employment Context, Justine Pila

Justine Pila

Section 39(1) of the Patents Act 1977 governs the ownership of inventions devised by employees in the course of their employment. Introduced ‘to codify in a few lines the accumulated common law experience’ prior to 1977, it does not expressly differentiate between employment fields, and has been widely assumed to apply indiscriminately, without regard to the particular context of employment. The purpose of this article is to revisit that assumption. In the argument made, section 39(1) was built around a private sector paradigm the courts’ departure from which is supported by a ‘rational reason’ in the Shanks v Unilever plc …

Patent Eligibility And Scope Revisited After Schütz V. Werit, Justine Pila

Justine Pila

This chapter responds to the contribution of Professor Ted Sichelman in the same volume by reconsidering the UK courts’ method of determining patent scope. Using my earlier work regarding the role of eligibility as a determinant of patent scope as the departure point for that reconsideration, I argue that the theory of “patent eligibility scope” proposed in Sichelman’s chapter runs against the grain of UK patent jurisprudence by virtue of its uncertain and open-ended policy nature, and is therefore unlikely to be accepted by the UK courts. On the other hand, recent UK cases such as Schütz v. Werit can …

Intellectual Property Rights And Detached Human Body Parts, Justine Pila

Justine Pila

This paper responds to an invitation by the editors to consider whether the intellectual property (IP) regime suggests an appropriate model for protecting interests in detached human body parts. It begins by outlining the extent of existing IP protection for body parts in Europe, and the relevant strengths and weaknesses of the patent system in that regard. It then considers two further species of IP right of less obvious relevance. The first are the statutory rights of ownership conferred by domestic UK law in respect of employee inventions, and the second are the economic and moral rights recognized by European …

Patent Litigation And The Internet, John R. Allison, Emerson H. Tiller, Samantha Zyontz

John R. Allison

Using both univariate comparisons and multiple regression techniques, we find that: (1) Internet patents and their two subtypes, broad Internet business models and narrower Internet business techniques, were litigated at a far higher rate than other (non-Internet patents, or NIPs)—they were between 7.5 and 9.5 times more likely to end up in infringement litigation, depending on the model we used. (2) Within the category of Internet patents, those on business models were litigated at a significantly higher rate than those on business techniques. (3) Across both Internet patents and NIPs, patents issued to small entities, especially individuals and small businesses, …

Hired To Invent Vs. Works Made For Hire: Resolving The Inconsistency Among Rights Of Corporate Personhood, Authorship, And Inventorship, Sean M. O'Connor

Articles

This Essay focuses on the interrelation of three legal doctrines that affect the allocation of ownership and attribution of products of the human mind. The first, corporate personhood, grants corporations rights of personhood similar to those of natural persons. The second, the work-made-for-hire doctrine (WMFH) under copyright law, allocates ownership and attribution for copyrightable works to the employer of the natural-person author—even where that employer is a nonnatural, legal person such as a corporation. And the third, shop rights and the hired-to-invent exception, permits courts to grant equitable licenses or assignments to employers for their employees’ inventions.

These three doctrines …

Race To The Bottom, Colleen Chien

Faculty Publications

The defensive patent arms race, and companies’ consequent focus on quantity rather than quality as they build their portfolios, causes them and others many problems. This article in Intellectual Asset Magazine exposes the role that practicing companies themselves and their patenting practices have had in keeping patent quality low, the backlog long, and patent trolls well-stocked with patents. It discusses various methods for fostering patent peace including by outlawing certain types of "arms" (a software patent ban), making patents harder to obtain or hold onto (i.e. by increasing registration/maintenance fees), and making patents less nuclear (e.g. by introducing an independent …

Princo Corp. V. Int'l Trade Comm'n: Patent Misuse No Longer A Deterrent To Anticompetitive Behavior In The Group Venture Context, Brian D. Hill

Journal of Business & Technology Law

No abstract provided.

Patents Fettering Reproductive Rights, Scott A. Allen

Indiana Law Journal

No abstract provided.

Economics Of The Independent Invention Defense Under Incomplete Information, Murat C. Mungan

Scholarly Publications

Patents lead to ex post deadweight loss arising from a noncompetitive market structure for the invention. Many have argued that introducing independent invention as a defense (IID) to patent infringement can increase social welfare by decreasing such deadweight loss at the price of a modest decrease in the number of inventions. This paper considers the effects of IID in a setting where R&D firms have incomplete information about their rivals. Four main results follow under incomplete information: (i) fewer things are invented under an IID regime; (ii) IID’s effects on welfare are ambiguous; (iii) IID is more likely to increase …

Patents 101: Patentable Subject Matter And Separation Of Powers, Max S. Oppenheimer

Vanderbilt Journal of Entertainment & Technology Law

The definition of statutory subject matter lies at the heart of the patent system. It is the reflection of Congress's policy decision as to what types of inventions one may patent. While the congressional definition of statutory subject matter (in what is now 35 U.S.C. § 101) has remained fundamentally constant since 1790, the Supreme Court has reinterpreted and redefined statutory subject matter several times, leaving lower courts with the frustrating task of trying to develop a coherent jurisprudence against a changing landscape. This inconstancy has introduced uncertainty for inventors who are trying to make the fundamental decision of whether …

Accountability In Patenting Of Federally Funded Research, Arti K. Rai, Bhaven N. Sampat

Faculty Scholarship

Bayh-Dole allows academic grantees to patent federally-funded research for purposes of promoting the commercialization of this research. To ensure commercialization goals are achieved, the Act requires grantees to report to funding agencies not only the existence of federally-funded patents but also utilization efforts they and their licensees/assignees are making.

Although reporting is a cornerstone of accountability under Bayh-Dole, information about grantee compliance with reporting requirements is incomplete and dated. In fact, the last significant study of the question dates back to the late 1990s and analyzes only 633 patents. Since that time, concerns have emerged that federally-funded university patents are …

Unlocking Health Canada’S Cache Of Trade Secrets: Mandatory Disclosure Of Clinical Trial Results, Matthew Herder

Articles, Book Chapters, & Popular Press

Health Canada should publicly disclose information about the safety and efficacy of pharmaceuticals, biologics and medical devices, and should especially disclose the designs and results of clinical trials. This disclosure is necessary to preserve public trust, address weaknesses in the evidence base, and protect Canadians from harm.

A prime example of the need for this disclosure involves selective serotonin reuptake inhibitors (SSRIs). Health Canada did not authorize SSRIs for sale to people younger than 19 years because of data from clinical trials showing risks of harm, including self-harm, associated with use of SSRIs in that age group. But Health Canada …

Patent Law's Audience, Mark D. Janis, Timothy R. Holbrook

Articles by Maurer Faculty

Many rules of patent law rest on a false premise about their target audience. Rules of patentability purport to provide subtle incentives to innovators. However, innovators typically encounter these rules only indirectly, through intermediaries such as lawyers, venture capitalists, managers, and others. Rules of patent scope strive to provide notice of the boundaries of the patent right to anyone whose activities might approach those boundaries, including, in theory, any member of the general public. But the rules of patent scope are practically incomprehensible to the general public. In this Article, we argue that rules of patent law should be designed …

Patent Litigation And The Internet, Samantha Zyontz, John R. Allison, Emerson H. Tiller, Tristan Bligh

Faculty Scholarship

Patent infringement litigation has not only increased dramatically in frequency over the past few decades,¹ but also has also seen striking growth in both stakes and cost.² Although a relatively rich literature has added much to our understanding of the nature, causes, and consequences of patent litigation during the past two decades,³ many interesting questions remain inadequately addressed. The nuances of and trends in patent litigation in different technology fields and industries, for example, are still understudied.⁴ Litigation of patents on new technologies has likewise received a dearth of attention. Here we seek to help begin …

Rand Patents And Exclusion Orders: Submission Of 19 Economics And Law Professors To The International Trade Commission, Arti K. Rai

Faculty Scholarship

In this comment to ITC Investigation 337-TA-745 (Certain Wireless Communication Devices, Motorola v. Apple) we, as teachers and scholars of economics, antitrust and intellectual property, remedies, administrative, and international intellectual property law, former Department of Justice lawyers and chief economists, a former executive official at the Patent and Trademark Office, a former counsel at the ITC Office of the General Counsel, and a former Member of the President’s Council of Economic Adviser take the position that ITC exclusion orders generally should not be granted under § 1337(d)(1) on the basis of patents subject to obligations to license on “reasonable and …